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23 

 

SYMBOL INFORMATION 

SYMBOL 

REFERENT 

SYMBOL 

REFERENT 

 

In vitro

 diagnostic 

medical device 

 

Manufacturer 

 

Consult 
instructions for use 

 

Catalogue number 

 

Temperature limit 

 

 

Caution 

 

Use-by date 

 

Humidity limitation 

 

Batch code 

 

CE mark 

 

Serial number 

 

RoHS compliance 

 

Authorized representative in the European 
Community 

 

This device does not belong to household waste and 
must  be  returned  to  a  collection  point  for  recycling 
electric and electronic devices according to local laws. 
If  it  contains  batteries,  the  batteries  should  be 
removed and disposed in   
accordance  with  locations  for  separate  collection  of 
spent batteries. 
 

 

 

Summary of Contents for Nealact

Page 1: ...Nealact Lactate meter User Manual NEA_LEC_EN_ind01_06 01 2021 ...

Page 2: ...hcare professional use It should not be used for diagnosis or screening of diseases The lactate test strip uses fresh capillary whole blood samples from the fingertips and from venous whole blood Professionals may use the test strips to test capillary and venous blood sample immediately home use is limited to capillary whole blood testing immediately Test Principle Your system measures the amount ...

Page 3: ...e quality control checks as directed 7 Keep the device and testing equipment away from young children Small items such as the battery cover batteries test strips lancets and vial caps are choking hazards 8 Use of this instrument in a dry environment especially if synthetic materials are present synthetic clothing and carpets etc may cause damaging static discharges that may cause erroneous results...

Page 4: ...reparing the Lancing Device for Blood Testing 10 Preparing the Puncture Site 10 Performing a Blood Test 11 METER MEMORY 13 Reviewing Test Results 13 BLUETOOTH PAIRING 14 MAINTENANCE 16 Battery 16 Replacing the Battery 16 Caring for Your Meter 17 Caring for Your Test Strips 17 Important Control Solution Information 18 MEASUREMENT RESULT READINGS 19 Lactate Testing 19 Reference Values 19 SYSTEM TROU...

Page 5: ......

Page 6: ...wer than usual follow the treatment advice of your healthcare professional Use only fresh whole blood samples to test your lactate Using other substances will lead to incorrect results If you are experiencing symptoms that are inconsistent with your test results and you have followed all the instructions given in this owner s manual contact your healthcare professional We do not recommend using th...

Page 7: ...nt Scroll the values in the memory M Button M Enter the meter memory Right Scroll Button Enter Bluetooth function and adjust value increment Scroll the values in the memory Strip Indication Light The indicator lights up in blue while the strip is inserted Test Strip Slot Insert test strip here to turn the meter on for testing Battery Compartment 1 2 3 4 5 6 7 9 8 ...

Page 8: ... Mode Gen Sample test Auto QC Mode QC Control solution test Memory Mode Date Time Error Message Alarm Symbol Measurement Unit Low Battery Symbol Lactate Symbol Test Strip Symbol Sample Drop Symbol Code of strip 1 2 3 4 5 6 7 8 9 10 11 12 13 ...

Page 9: ... Test results might be wrong if the contact bar is not fully inserted into the test slot NOTE The Nealact meter should only be used with Nealact Lactate test strips Using other test strips with this meter can produce inaccurate results Absorbent Hole Test Strip Handle Confirmation Window Contact Bars 1 2 3 4 ...

Page 10: ...ashing in sequence press or to select the correct number Press M 2 Setting the time format Press or to select the desired time format 12h or 24h Press M 3 Setting the time With the HOUR MINUTE flashing in sequence press or to select the correct number Press M 4 Setting the buzzer With the buzzer displays press or to switch between On and Off Press M 5 Deleting the memory With dEL and on the displa...

Page 11: ... the alarm beeps press to switch it off Otherwise it will beep for 2 minutes then switch off 7 Setting the Bluetooth function With BLE on the display press or to select On or OFF Press M NOTICE This function is referring to the Bluetooth data transmission If On is selected your result will be transmitted automatically right after the test Congratulations You have completed all settings NOTE These ...

Page 12: ...ASURING MODE Lactate Testing The meter provides you with one mode for measuring Gen You can start with the meter switched off Insert a test strip to turn on the meter The screen will display a flashing and LAC ...

Page 13: ...provided with the meter and can be purchased separately Please make sure you have those items needed for a test beforehand Performing a Control Solution Test To perform a control solution test you will need b c and d 1 Insert the test strip to turn on the meter Insert the test strip into the meter Wait for the meter to display and a flashing 2 Apply control solution g Shake the control solution vi...

Page 14: ...he display Compare this result with the range printed on the test strip vial and it should fall within this range If not please read the instructions again and repeat the control solution test With QC displayed the meter will store your test result in memory under QC NOTE The control solution range printed on the test strip vial is for control solution use only It is not a recommended range for yo...

Page 15: ...fluence on the test value obtained Blood from a site that has not been rubbed exhibits a measurably different lactate concentration than blood from the finger When the puncture site was rubbed prior to blood extraction the difference was significantly reduced Please follow the suggestions below before obtaining a drop of blood Wash and dry your hands before starting Select the puncture site Rub th...

Page 16: ...ly squeeze the punctured area to obtain another drop of blood Be careful NOT to smear the blood sample 3 Apply the sample j Gently apply the drop of blood to the absorbent hole of the test strip at a tilted angle Confirmation window should be completely filled if enough blood sample has been applied Do NOT remove your finger until you hear a beep sound NOTE For a lactate test make sure to perform ...

Page 17: ...vice for assistance 4 Read Your Result The result of your test will appear after the meter counts down to 0 The result will be stored in the memory automatically 5 Eject the used test strip k Eject the test strip by pushing the eject button on the side Use a sharp bin to dispose of used test strips The meter will switch itself off automatically Always follow the instructions in the lancing device ...

Page 18: ...ored in the meter each time you press Press to scroll down to view the old test result and press to scroll up to see the new one Keep pressing to scroll up to the first reading you will see toP on the meter display keep pressing to scroll down to the last reading you will see End on the meter display Press and hold M to switch off the meter 3 Exit the meter memory Keep pressing the M and the meter...

Page 19: ...ition and to achieve better diabetes control System Requirement For the requirement of OS version please find on App Store or Google Play when you download the app Please contact your local customer service or place of purchase for assistance Please note that you must complete the pairing between meter and Bluetooth receiver before transmitting data Pairing with your mobile device 1 Turn on the Bl...

Page 20: ...t Make sure your device supports Bluetooth Smart Technology Also make sure the Bluetooth setting on your device is turned on and the meter is within the receiving range before transmitting the data Please find OS version requirement on App Store or Google Play when you download the app The Bluetooth functionality is implemented in different ways by the various mobile device manufacturers the compa...

Page 21: ...ttery To replace the batteries l make sure the meter is turned off 1 Press the edge of the battery cover and lift it up to remove 2 Remove the old batteries and replace with two 1 5V AAA size alkaline batteries 3 Close the battery cover If the batteries are inserted correctly you will hear a beep afterwards NOTE Replacing the batteries does not affect the test results stored in the memory As with ...

Page 22: ...al storage case Avoid dropping and heavy impact Avoid direct sunlight and high humidity Meter Disposal The used meter should be treated as contaminated that may carry a risk of infection during measurement The batteries in this used meter should be removed and the meter should be disposed in accordance with local regulations The meter falls outside the scope of the European Directive 2012 19 EU Di...

Page 23: ...o the test strip package insert Important Control Solution Information Use only our Nealact lactate control solutions with your meter Do not use the control solution beyond the expiration date or 3 months after first opening Write the opening date on the control solution vial and discard the remaining solution after 3 months It is recommended that the control solution test be done at room temperat...

Page 24: ...valent results and are displayed in millimoles of lactate per liter of blood mmol L Desirable range Lactate 0 3 to 2 4 mmol L Source Mary A Williamson L Michael Snyder 10th ed 2015 Wallach s interpretation of diagnostic tests pathways to arriving at a clinical diagnosis Philadelphia Wolters Kluwer Please consult your doctor to determine a target range that works best for you ...

Page 25: ...stem operation range Repeat the test after the meter and test strip are within the operation temperature range E 0 E A E E E C Problem with the meter Repeat the test with a new test strip If the meter still does not work please contact the customer service for assistance E F Appears when test strip is removed while counting down or insufficient blood volume Review the instructions and repeat test ...

Page 26: ...lood sample Repeat the test using a new test strip with larger volume of blood sample Defective test strip Repeat the test with a new test strip Sample applied after automatic switch off 1 minute after last user action Repeat the test with a new test strip Apply sample only when flashing appears on the display Defective meter Please contact customer services 3 If the control solution testing resul...

Page 27: ... too warm or too cold Control solution meter and test strips should be at room temperature 20 C to 25 C 68 F to 77 F before testing Defective test strip Repeat the test with a new test strip Meter malfunction Please contact customer services Improper working of meter and test strip Please contact customer services ...

Page 28: ...on Batch code CE mark Serial number RoHS compliance Authorized representative in the European Community This device does not belong to household waste and must be returned to a collection point for recycling electric and electronic devices according to local laws If it contains batteries the batteries should be removed and disposed in accordance with locations for separate collection of spent batt...

Page 29: ...rning Operating Condition 10 C to 40 C 50 F to 104 F and 10 to 85 R H non condensing Meter Storage Transportation Conditions 20 C to 60 C 4 F to 140 F and 10 to 93 R H non condensing Strip Storage Transportation Conditions 2 C to 30 C 35 6 F to 86 F and 10 to 85 R H non condensing Measurement Units Fixed mmol L Measurement Range 0 3 to 22 mmol L Expected Service Life 5 years Operating Altitude Up ...

Page 30: ...25 PURCHASE INFORMATION Name Cat number Content Nealact Lactate test strips TD 4663 Vial of 25 strips Nealact Lactate control solution TD 4924 1x tube 4mL Nealact Lactate meter TD 4216 Meter batteries ...

Page 31: ...ibuted by Natech SAS 479 boulevard Maréchal Foch 13300 Salon de Provence France www natech healthcare com TaiDoc Technology Corporation B1 7F No 127 Wugong 2nd Rd Wugu Dist 24888 New Taipei City Taiwan www taidoc com MedNet EC REP GmbH Borkstraβe 10 48163 Mϋnster Germany ...

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